Phase 1Recruiting
A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants and in Participants With Cardiovascular Risk Factors
A Single-Center, Double-Blind, Randomized, Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses of ACI-19764 in Healthy Participants and in Participants With Cardiovascular Risk Factors
- Sponsor
- AC Immune SA (Industry)
- Enrolment
- 114 planned
- Conditions
- Healthy Participants; Obesity; Type 2 Diabetes Mellitus (T2DM)
- Interventions
- Placebo; ACI-19764 at dose A1; ACI-19764 at dose A2; ACI-19764 at dose A3; ACI-19764 at dose A4; ACI-19764 at dose A5; ACI-19764 at dose A6; ACI-19764 at dose B1; ACI-19764 at dose B2; ACI-19764 at dose B3; ACI-19764 at dose C1
- Ages
- adults, older adults
- Registry
- NCT07463196
From the registry
The main purposes of this study are: * to investigate the safety and tolerability of ACI-19764 when it is administered to healthy participants and participants with cardiovascular risk factors * to determine how quickly and to what extent ACI-19764 is absorbed, transported, metabolized, and excreted by the body (fasted and after a meal) * to determine the effect of ACI-19764 on specific markers in the blood that are part of the immune system The effects of ACI-19764 will be compared with the effects of a placebo. ACI-19764 is a brain-penetrant NLRP3 inhibitor. The study consists of 3 parts, Part A (SAD, single ascending dose) and Part B (MAD, multiple ascending doses) in healthy participants, and Part C (one multiple-dose level) in participants with cardiovascular risk factors. Participants in Part A will receive the study compound once, and participants in Part B and Part C will receive the study compound multiple times (daily over 14 and 28 days, respectively). Parts A and B will be divided into different groups of participants to test different doses of ACI-19764.
Primary outcomes
- Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely related, possibly related or probably related)
- Vital signs: Change from baseline in blood pressure
- Vital signs: Change from baseline in respiratory rate
- Vital signs: Change from baseline in pulse rate